Can the Trump Administration Finally Drag Drug Ads Into FDA Compliance?

Well the Doc opened up the old mailbag today and here’s what poured out.

Dear Dr. Ads,

There I was, minding my own business and clicking through the Boston Globe, when I came across Gerry Smith’s Bloomberg piece about a pharmaceutical company that actually did what the Food and Drug Administration said to do about its TV spots.

Alnylam Pharmaceuticals Inc. has stopped airing a TV commercial for its new heart medicine, a sign that the Trump administration’s crackdown on the industry’s ubiquitous drug ads is having an impact on the media landscape.

Alnylam was one of many companies to get letters last month from the US Food and Drug Administration calling out what the agency believes are misleading commercials. Most of the letters, sent to companies including AstraZeneca Plc, Bristol Myers Squibb Co., and AbbVie Inc., detail concerns with their online, broadcast, and print marketing, ranging from hiring actors who appear too healthy to omitting key safety risks.

Whaddaya think, Doc – is the Food and Drug Sadministration finally breaking through after years of being told by drugmakers to screw off?

– Medicine Man

Dear MM,

As TV reporters often say (when they have nothing to say), time will tell. Meanwhile, the Alnylam commercial in question – for the new heart medication Amvuttra – is nowhere to be found on Google or YouTube. According to the Bloomberg piece, however, the spot showed patients who were way too exuberant while “traveling and participating in activities like whale-watching and jumping up and down while cheering at a football game.”

The ad was misleading, the FDA said, because it suggested that patients “can be carefree” about the heart disease that the drug treats.

“The totality of these claims and presentations also misleadingly suggests that treatment with Amvuttra will broadly improve a patient’s overall quality of life when this has not been demonstrated,” wrote George Tidmarsh, the head of the FDA’s Center for Drug Evaluation and Research, on Sept. 9. The company was asked to address the violations, including by halting communications the FDA found misleading.

In response, Alnylam pulled the ad, saying “It’s standard practice to pause advertising while changes are being considered.”

(Actually, it’s kind of not, as the Doc recently chronicled regarding the FDA’s attempted crackdown on “surreal” ads. )

The Alnylam pullback means the FDA is batting .010 so far out of its 100 cease-and-desist letters to pharmaceutical companies.

The Doc’s diagnosis:  Please note that Alnylam has a market cap of around $60 billion compared to, say, Pfizer’s $155 billion. Or AstraZeneca’s $255 billion. Or AbbVie’s $413 billion. So the FDA basically hooked one of the minnows in the Pharma pond. Wake us when they land a big fish, yeah?